TEL AVIV, Israel – A home-based, smartphone-enabled urinalysis kit from Healthy.io has received clearance from the U.S. Food and Drug Administration. The Dip.io kit, the first product in the company’s digital health product portfolio, enables patients to conduct clinical grade urine tests at home. The FDA approval marks the first time the agency has cleared a device based solely on existing smartphone cameras for Class II clinical claims. “We are in the midst of the biggest economic value transition in history,” said Yonatan Adiri, founder and CEO of Healthy.io, in a statement. “Healthy.io is proud to have its pioneering technology withstand the rigor of FDA Class II trials and continues to pursue its mission of ushering in the era of the ‘medical selfie’ as it transforms embedded smartphone cameras into clinical-grade medical scanners.” The company is currently expanding its “medical selfie” portfolio to standardized assessment of chronic wounds.
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